Self-Help for Stress Related to COVID-19

NCT ID: NCT04762173

Last Updated: 2021-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

585 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-06

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a study on internet-based self-help for stress related to the COVID-19 pandemic. College and university students who score in the moderate or higher range on a stress measure during the COVID-19 pandemic will be invited to participate in this study. Participants will be randomly assigned to receive access to an internet-based self-help program for stress resilience and coping with the COVID-19 pandemic or care as usual. Stress and psychosocial symptoms will be assessed via questionnaire at baseline (pre-randomization), one month post-randomization, and three months post-randomization.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Online self-help intervention

Participants are provided access to two online self-help programs provided by SilverCloud Health. One program is designed to support general stress resilience using principles and techniques from positive psychology and cognitive-behavioral therapy. The other program is designed to support coping with pandemic-related stressors using psychoeducation and cognitive-behavioral therapy and grief therapy principles. Participants have access to both programs and can proceed through them in the order and pace of their choosing. The online self-help intervention is fully self-guided.

Group Type EXPERIMENTAL

Online self-help intervention

Intervention Type DEVICE

Access to two online, self-guided programs available on the SilverCloud Health website.

Care as usual

Participants are provided information about how to contact the counseling center at their college and/or in the local community using the phone number and website of their counseling center (if available), as well as the Substance Abuse and Mental Health Services Administration treatment locator.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Online self-help intervention

Access to two online, self-guided programs available on the SilverCloud Health website.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SilverCloud Health

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Moderate or higher stress as assessed using Stress subscale of the Depression Anxiety Stress Scales-Short Form
* Current student at a college or university in the United States
* Able to provide consent
* Proficient in English

* Current participant in separate randomized controlled trial being conducted by this research group examining efficacy of SilverCloud Health interventions

Exclusion Criteria

* Below age 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Penn State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michelle G. Newman

Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gavin N Rackoff, MS

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Pennsylvania State University

University Park, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Rackoff GN, Fitzsimmons-Craft EE, Taylor CB, Eisenberg D, Wilfley DE, Newman MG. A Randomized Controlled Trial of Internet-Based Self-Help for Stress During the COVID-19 Pandemic. J Adolesc Health. 2022 Aug;71(2):157-163. doi: 10.1016/j.jadohealth.2022.01.227. Epub 2022 Feb 4.

Reference Type DERIVED
PMID: 35351353 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00015766

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

StressLess Yoga Study
NCT06260098 COMPLETED NA